May 3 (UPI) -- Pharmaceutical giant Eli Lilly said Wednesday results from a Phase 3 study on its Alzheimer's treatment slowed clinical cognitive and functional decline by 35% compared with a placebo.
The company said the late-stage study of the drug donanemab also resulted in a 40% less decline in the ability to perform daily living activities over the past 12 months.
In the randomized, double-blind, placebo-controlled study, Eli Lilly said researchers measured cognition and activities of daily living such as managing finances, driving, engaging in hobbies and conversing about current events.
Donanemab showed statistically significant clinical benefits, the company said. It will proceed with regulatory submissions to the Food and Drug Administration and other global regulators for approvals.
"Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer's disease by elucidating basic mechanisms of AD pathology and discovering imaging and blood biomarker tools to track the pathology," Daniel Skovronsky, Lilly's chief scientific and medical officer and president of Lilly Research Laboratories, said in a statement.
"We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer's disease in this trial. This is the first Phase 3 trial of any investigational medicine for Alzheimer's disease to deliver 35% slowing of clinical and functional decline," he said.
This is a turnaround event for Lilly, which was denied accelerated approval of donanemab by the Food and Drug Administration in January because not enough patients had received the drug for a year.
The application for accelerated approval had been based on a small, mid-stage trial, and some patients were permitted to stop treatment after half a year.
The accelerated approval would not have resulted in Medicare coverage for the drug, as the program would not include amyloid-lowering Alzheimer's medications unless they receive full approval from the FDA.
The new, final-stage trial study enrolled people with early symptomatic Alzheimer's disease, which includes mild cognitive impairment and the mild dementia stage of the disease.
Lilly said the 35% slowing of progression was the outcome of a trial involving 1,182 patients with early-stage Alzheimer's. The company said the application for full FDA approval would come this quarter.
Side effects during the study were noted, which have been reported with similar drugs. Some 24% of the subjects had brain swelling, while 31.4% experiences bleeding in the brain,
Participants completed their course of treatment with donanemab once they reached a prespecified level of amyloid plaque clearance.
"Amyloid plaque is a defining pathophysiological feature of Alzheimer's disease," Eric Reiman, CEO of Banner Research, one of the research sites for the trial, said in a statement.
"This study's topline results provide compelling support for the relationship between amyloid plaque removal and a clinical benefit in people with this disease."
In 2021, Biogen's aducanumab, marketed under the brand name Aduhelm, became the first drug to be approved for the debilitating form of dementia since 2003. Concerns have also been raised about its efficacy. Medicare severely limited coverage and many Medicare Advantage plans followed that lead.
In May 2022, Biogen announced was closing the commercialization unit that marketed Anduhelm, and as a result it generally disappeared from the market.
However, Eisai Co.'s Leqembi, co-marketed with Biogen, also showed it slowed disease progression, and it received FDA approval in January. The Centers for Medicare & Medicaid Services, however, rejected a request to cover the drug, which has a $26,000-a-year price tag.
CMS said "there is not enough evidence" that the treatment is reasonable and necessary.
According to the Centers for Disease Control and Prevention, as many as 5.8 million Americans lived with Alzheimer's disease in 2020. The agency said the number of patients doubles every five years beyond age 65 and is expected to reach 14 million by 2060.